A temperature sensing lavage catheter

ABSTRACT

A catheter for measuring temperature of a fluid in a body cavity includes a catheter body having a proximal end and an opposite distal end with a tip; an inflow lumen; an outflow lumen; and a temperature sensor lumen having a temperature sensor. The temperature sensor lumen is arranged closer to the outflow lumen and to the inflow lumen in the catheter body. The temperature sensor includes a sensing element positioned at the tip of the distal end to measure a temperature of a fluid in a body cavity when the distal end of the catheter body is inserted into a body cavity.

FIELD OF THE INVENTION

The present invention generally relates to the measurement of thetemperature of a fluid in a body cavity of a patient with the use of acatheter comprising a temperature sensor. More particularly, the presentinvention generally relates to the measurement of the temperature of afluid in a body cavity of a patient during therapeutic irrigation of thebody cavity with the fluid with a lavage catheter comprising atemperature sensor.

BACKGROUND OF THE INVENTION

During therapeutic irrigation, also referred to as lavage, a patient'sbody cavity is typically infused with one or more fluids or irrigants,or one or more solutions for therapy or diagnosis. For example, apatient's body cavity may be infused with therapeutic fluids ornutritive agents, or a patient's body cavity may be infused withchemotherapeutic fluids during treatment of a cancer. This way, apatient's body cavity and more particularly the internal surface of thebody cavity may be washed by flowing the cavity with for example wateror an irrigant for therapy or diagnosis.

Examples of therapeutic irrigation are an antiseptic lavage, abronchoalveolar lavage, a gastric lavage, a peritoneal lavage, anarthroscopic lavage, a ductal lavage, a nasal irrigation, an ear lavage,etc.. A bronchoalveolar lavage is for example a medical procedure inwhich a bronchoscope is passed through the mouth or nose of a patientinto the lungs and where fluid is squirted into a small part of the lungand then collected for examination. It is typically performed todiagnose lung disease. Bronchoalveolar lavage is commonly used todiagnose infections in for example people with immune system problems,pneumonia in people on ventilators, some types of lung cancer, andscarring of the lung. It is the most common method used to sample theepithelial lining fluid and to determine the protein composition of thepulmonary airways. It is often used in immunological research as a meansof sampling cells or pathogen levels in the lung. Gastric lavage, alsocommonly called stomach pumping or gastric irrigation, is the process ofcleaning out the contents of the stomach. Gastric lavage involves thepassage of a tube, such as for example an Ewald tube, via the mouth ornose down into the stomach followed by sequential administration andremoval of small volumes of liquid. Small amounts of warm water orsaline are administered and, via a siphoning action, removed again.Diagnostic peritoneal lavage, also referred to as DPL, or diagnosticperitoneal aspiration, also referred to as DPA, is a surgical diagnosticprocedure to determine if there is free floating fluid such as blood inthe abdominal cavity. A catheter is inserted towards the pelvis andaspiration of material attempted using a syringe. If no blood isaspirated, saline is infused and then drained to be sent for analysis.Ductal lavage is a method used to collect cells from milk ducts in thebreast. A catheter is inserted into the nipple, and a small amount ofsalt water is released into the duct. The water picks up breast cellsand is removed. Ductal lavage may be used in addition to clinical breastexamination and mammography to detect breast cancer. A pulsed lavage isyet another example of therapeutic irrigation and it consists indelivering an irrigant, usually normal saline, under direct pressurethat is produced by an electrically powered device and is useful incleaning e.g. chronic wounds.

The one or more fluids or the one or more solutions used for therapeuticirrigation may originate from a liquid-filled bag or container and afluid delivery line may deliver the fluids under gravity and/or appliedpressure from the container to the patient's body cavity. In most of theexamples above, a catheter is introduced in the body cavity to deliverthe one or more fluids or solutions to the body cavity. The fluid may beremoved from the body cavity after the body cavity has been washed byflowing the cavity with the fluid, for example when the fluid has flownthe body cavity enough according to the requirements for therapy and/orwhen the fluid has flown the body cavity enough for diagnosis purposes.The direct delivery of fluids to a patient's body cavity allows forhigher doses of treatment, and thereby increases the efficiency of thetreatment. Additionally, the local concentration of fluids within apatient's body cavity minimizes the rest of the patient's body exposureto the treatment, thereby reducing some side effects of the treatment.In the meantime, heating the solution may also improve the absorption offluid by cells of the body cavity.

A catheter is a thin tube made from medical grade materials that can beinserted into the body to treat diseases or perform a surgicalprocedure. Catheters can be inserted into a body cavity, duct, orvessel. Functionally, they allow drainage, administration of fluids orgases, access by surgical instruments, and perform a wide variety ofother tasks depending on the type of catheter. The process of insertinga catheter is “catheterization”. In most uses, a catheter is a thin,flexible tube although catheters are available in varying levels ofstiffness depending on the application. A catheter left inside the body,either temporarily or permanently, may be referred to as an indwellingcatheter, for example, a peripherally inserted central catheter. Apermanently inserted catheter may be referred to as a “permcath”.

When flowing a body cavity of a patient with a fluid such as done—amongothers—in the context of therapeutic irrigation or lavage, it isimportant to maintain the temperature of the fluid in the fluid deliverylines within a desirable and safe temperature range upon entering thepatient so as to eliminate any potential risk of thermal shock andinjury induced by the fluids to the patient. It is therefore veryimportant to accurately monitor the temperature of the fluid as close aspossible to the body cavity such that the temperature of the fluid iswithin a desirable and safe temperature range to allow for exampletreatment and/or diagnosis of the body cavity, while eliminating anypotential risk of thermal shock and injury induced by the fluid to thepatient and more particularly to the body cavity. If the fluid is cooledor heated too much, there exists a risk of degradation of the nature andof the stability of the fluid delivered to the patient, which couldendanger his health and/or jeopardize the efficiency of the treatment. Avery precise control of the temperature of the fluid in the body cavityenables an appropriate treatment of the body cavity and/or anappropriate collection of for example cells of the body cavity fordiagnosis purposes.

Several examples of catheter comprising one or more temperature sensorsexist. However, there is a risk that a temperature sensor fails. When atemperature sensor fails, the failed catheter may have to be replaced.This compounds patient discomfort and it also increases the risk ofinjury and infection for the patient when the failed catheter is removedfrom the patient's body and when a new catheter is introduced asreplacement. A further risk resulting from possible failure of atemperature sensor is that the failure will not be detected and thatother systems such as for example the fluid delivery system might dependon the erroneous temperature sensor reading. For example, the fluiddelivery system may fail to properly operate when relying on atemperature reading provided by a failed temperature sensor and maydelivery fluid at a too high or too low temperature, thereby riskingthermal shock and injury induced by the fluid to the patient and moreparticularly to the body cavity.

The U.S. Patent Application US2002/0082587A1 entitled “Foley CatheterHaving Redundant Temperature Sensors and Method” describes a Foleycatheter with redundant temperature sensors which is introduced into thebladder of a patient to drain urine from the bladder. The Foley catheterof US2002/0082587A1 comprises a drainage lumen, an integratedtemperature sensor lumen and a balloon inflation lumen. The integratedtemperature sensor of US2002/0082587A1 comprises an integrated sensorelement 35 visible on FIG. 2 of US2002/0082587A1 which is advanced viathe drainage lumen to be disposed at the distal end of the catheter.When the integrated sensor element 35 of US2002/0082587A1 fails, theuser of the catheter attaches an adapter to the catheter and anadditional sensor with an additional temperature sensor 38 visible onFIG. 2 of US2002/0082587A1 advances through the drainage lumen of thecatheter to position the temperature sensor 38 in the distal end of thecatheter.

The Foley catheter described in US2002/0082587A1 requires the use of twotemperature sensors 35;38 positioned at the distal end of the catheterto guarantee an accurate and reliable measurement of the temperature ofthe urine in the bladder of the patient. The distal end of the cathetermust be designed to be able to simultaneously host both temperaturesensors for a reliable measurement. The design of the catheter istherefore not compact, which compounds discomfort and possibly injuryfor the patient upon introduction of the catheter along the ureter orany other body cavity. Additionally, the temperature sensor wires ofboth temperature sensors are advanced towards the distal end of thecatheter via the drainage lumen. In other words, the temperature wiresare in direct contact with urine in the fluid passage in the drainagelumen when urine is being drained from the bladder by the catheter. Asurine flows in the drainage lumen, the temperature sensors ofUS2002/0082587A1 are consequently contaminated by the direct contactwith the urine. The patient could be endangered if the temperaturesensor was not thoroughly cleaned before being introduced in thecatheter, or if the temperature sensor was not properly electricallyisolated from the fluid.

SUMMARY OF THE INVENTION

It is an objective of the present invention to disclose a catheter formeasuring temperature of a fluid in a body cavity which overcomes theabove identified shortcomings of existing solutions. More particularly,it is an objective to disclose a catheter with an integrated temperaturesensor which indirectly and accurately measures the temperature of afluid in a body cavity.

According to a first aspect of the present invention, the above definedobjectives are realized by a catheter for measuring temperature of afluid in a body cavity, wherein the catheter comprises a catheter bodycomprising a proximal end and an opposite distal end comprising a tip;and wherein the catheter body further comprises:

-   -   an inflow lumen extending from an irrigation opening in a        sidewall of the tip to the proximal end;    -   an outflow lumen extending from a drainage opening in the        sidewall of the tip to the proximal end; and    -   a temperature sensor lumen comprising a temperature sensor;        wherein the temperature sensor lumen is arranged closer to the        outflow lumen than to the inflow lumen in the catheter body; and        wherein the temperature sensor comprises a sensing element        positioned in the temperature sensor lumen at the tip of the        distal end; and wherein the sensing element is configured to        measure a temperature of a fluid in a body cavity when the        distal end of the catheter body is inserted in a body cavity.

The catheter according to the present invention is used to deliver afluid for lavage purposes and/or for therapeutic purposes and/or fordiagnosis purposes to a body cavity of a patient in the context of alocalized treatment of a specific body cavity. The catheter according tothe present invention directly delivers the fluid to the body cavity asthe catheter is introduced directly into the body cavity. The efficiencyof the fluid on the body cavity is therefore maximized: the fluid isonly delivered in the body cavity. The precision of thetreatment/diagnosis is also maximized. The impact of the treatmentand/or diagnosis on the patient is also minimized as the delivery of thefluid is local and does not spread to the whole body of the patient. Aninflow lumen is arranged in the catheter body to deliver a fluid to thebody cavity when the catheter is introduced in the body cavity. Anoutflow lumen is arranged in the catheter body to drain a fluid from thebody cavity when the catheter is introduced in the body cavity. Thecatheter according to the present invention allows an indirect andaccurate measurement of the temperature of a fluid in a body cavity whenthe catheter is introduced in the body cavity. The catheter according tothe present invention comprises an integrated temperature sensor,wherein the sensing element is positioned at the tip of the distal endof the catheter. When the distal end of the catheter according to thepresent invention is introduced into a body cavity, the sensing elementis positioned as close as possible to the fluid in the body cavity. Thesensing element is in direct contact with the tip of the catheter body.The outside surface of the tip of the catheter body is in direct contactwith the fluid in the body cavity. The sensing element measures thetemperature of the fluid through the tip of the catheter body. In otherwords, the temperature sensor according to the present inventionindirectly measures the temperature of the fluid. The sensing elementaccording to the present invention is arranged in the catheter bodycloser to the outflow lumen than to the inflow lumen. Preferably, thedistance between the temperature sensor lumen in which the sensingelement is positioned and the outflow lumen is twice the distancebetween the temperature sensor lumen and the inflow lumen.Alternatively, the distance between the temperature sensor lumen inwhich the sensing element is positioned and the outflow lumen is morethan twice the distance between the temperature sensor lumen and theinflow lumen. By being closer to the outflow lumen than to the inflowlumen in the catheter body, the sensing element according to the presentinvention allows a more accurate and a more reliable measurement of thetemperature of a fluid in the body cavity. The sensing element accordingto the present invention provides a user of the catheter with a morerealistic feedback on the actual temperature of the fluid in the bodycavity. The sensing element according to the present invention can forexample indirectly measure the temperature of a fluid in a body cavity.The catheter according to the present invention can for exampleindirectly measure the temperature of a fluid in a body cavity with anaccuracy comprised between +/−1° C. and +/−0.1° C., preferably with anaccuracy or precision comprised between or equal to +/−0.5° C. and+/−0.1° C.

According to the present invention, the catheter body comprises atemperature sensor lumen which is configured to host the temperaturesensor. The temperature sensor lumen is formed in the catheter body. Thetemperature sensor lumen is independent from the inflow lumen, and thetemperature sensor lumen is also independent from the outflow lumen. Inother words, the temperature sensor lumen is neither in fluidcommunication with the inflow lumen nor in fluid communication with theoutflow lumen. This way, the temperature sensor and the sensing elementaccording to the present invention are never in direct contact with thefluid in the catheter body. The temperature sensor and the sensingelement according to the present invention are therefore nevercontaminated by direct contact with a fluid in body cavity whenmeasuring the temperature of the fluid. Additionally, the temperaturesensor according to the present invention may be removed from thecatheter, and because neither the temperature sensor nor the sensingelement have ever been contaminated by direct contact with a fluid, thetemperature sensor and the sensing element do not endanger the patientwhen the temperature of the fluid is measured.

The outflow lumen and the inflow lumen according to the presentinvention are independent from each other in the catheter body. In otherwords, the outflow lumen and the inflow lumen are arranged side by sidein the catheter body of the catheter according to the present invention.In other words, the outflow lumen and the inflow lumen are arranged nextto each other in the catheter body. Alternatively, the outflow lumencomprises the inflow lumen. In other words, the outflow lumen and theinflow lumen can alternatively be in fluid communication with each otherwhen the inflow lumen is completely comprised in the outflow lumen. Thisway, the footprint of the catheter body is significantly reduced.

The distal end of the catheter body is designed to be easily introducedinto the body cavity, without injuring the patient. For example, the tipof the catheter comprises silicon, such as for example clear silicone.Alternatively, the tip of the catheter according to the presentinvention comprises blue radiopaque silicone. The tip of the distal endof the catheter for example comprises clear 60 ShA silicone such as forexample EL R402/60 and barium sulfate Blanc Fixe Grade HD 80. Accordingto the present invention, the catheter body comprises silicone, such asfor example silicone rubber. This way, the catheter body is heatresistant, low-temperature flexible and resistant to UV, ozone andradiation aging. Alternatively, the catheter body comprisespolycarbonate. This way, the catheter is hygienic, easy and cheap tofabricate in series and in large quantities, and it can easily bedisposed. Alternatively, the catheter body is made of thermoplastic.Alternatively, a catheter inflation valve comprises a polypropylenebody. All materials used in the catheter according to the presentinvention are to meet ANSI/AAMI/ISO 10993-1:2003 requirements. Thecatheter body according to the present invention is cylindrical and hasa diameter to conform to the French scale or French gauge systemcommonly used to measure the size of a catheter. The French size isthree times the diameter in millimeters. For example, the French size ofthe catheter according to the present invention is 16. Alternatively,the French size of the catheter according to the present invention is18. The French size is understood in the context of the presentinvention as a measure of the outer diameter of a catheter.

According to the present invention, the sensing element is for example athermistor. More particularly, the sensing element according to thepresent invention is for example a coated thermistor used to minimizethe risk of health hazard for the patient when the catheter isintroduced into a body cavity. For example, the sensing elementaccording to the present invention comprises a housing comprisingpolyvinyl chloride or PVC, such as for example a white medical gradePVC. The sensing element may further comprise a thermistor side portwith comprises silicone such as a silicone rubber. This way, the sensingelement is heat resistant, low-temperature flexible and resistant to UV,ozone and radiation aging. Alternatively, the temperature sensor is athermocouple, a resistance thermometer, a silicon bandgap temperaturesensor, a thermostatic switch, an infra-red temperature sensor, etc.

According to the present invention, a body cavity is for example anatural body cavity, such as for example a bladder, a stomach, anabdomen, a lung, etc.. Alternatively, a body cavity in the context ofthe present invention is for example an artificial body cavity, such asfor example the abdomen of a patient closed by a surgeon during surgery,or an artefact enclosing a part or the entirety of an organ of a patientin which the circulation of a fluid delivered by the catheter wouldoccur.

A fluid according to the present invention is a highly concentrated,heated fluid directly delivered to a body cavity of a patient duringlavage or therapeutic irrigation in the context of a treatment or adiagnosis. For example, a fluid according to the present invention maynot comprise chemotherapeutic agents. Alternatively, a fluid accordingto the present invention is any suitable irrigant and/or solution whichmay be delivered to a body cavity by a catheter. For example, a fluidaccording to the present invention is a normal saline solution.Alternatively, a fluid according to the present invention is a highlyconcentrated, heated therapeutic fluid directly delivered to the bladderof the patient before, immediately after of after TransurethralResection of Bladder Tumors surgery, also referred to as TURBT surgery.Alternatively, a fluid according to the present invention is a highlyconcentrated, heated therapeutic fluid directly delivered to the bladderof the patient before, immediately after of after a hyperthermicintra-vesical chemotherapy treatment, also referred to as HIVEC.Alternatively, a fluid according to the present invention is any fluidwhich is suitable and compatible with a hyperthermic treatment, or anytherapeutic fluid and/or nutritive agents and/or chemotherapeutic fluidsand/or immunotherapy fluids delivered during a treatment or a diagnosis.The fluid according to the present invention has a temperature comprisedbetween 37 and 45° C., more particularly comprised between 39.5 and40.5° C., or more particularly comprised between 41.8 and 42° C., ormore particularly comprised between 43 and 44° C. when it is in the bodycavity. Delivery of the fluid to the body cavity can for example lastseveral minutes, preferably one hour, or several hours.

According to the present invention, the inner diameter of the outflowlumen is larger than the inner diameter of the inflow lumen. Moreparticularly, a ratio of the inner diameter of the inflow lumen over theinner diameter of the outflow lumen is comprised between 0.6 and 1. Thisway, obstructions in the outflow lumen due to body tissues being drainedfrom the body cavity are prevented. Additionally, potential pressureissues in the fluid circulation system formed by the catheter areprevented thanks to a larger inner diameter of the outflow lumen thanthe inner diameter of the inflow lumen. This way, fluid that has alreadyflown in the body cavity does not flow back into the inflow lumen. Therisk of contamination of the inflow lumen by fluid that has been incontact with tissue is therefore lowered. The catheter according to thepresent invention is for example designed to meet or exceed a flow rateper A.S.T.M. F623-99 method for Foley catheters.

According to an optional aspect of the invention, the sensing element ispositioned closer to the drainage opening than to the irrigation openingin the catheter body.

This way, the sensing element provides a more accurate temperaturemeasurement of the temperature of the fluid in the body cavity by alsomeasuring the temperature of the fluid when the fluid exists the bodycavity. Measuring the temperature of the fluid in the body cavity andthe fluid being drained from the body cavity provides a more realisticmeasurement of the actual temperature of the fluid in the body cavity.

According to an optional aspect of the invention, the temperature sensorlumen is arranged in the catheter body at the inside periphery of thecatheter body.

This way, the sensing element is arranged in the temperature sensorlumen at the tip of the distal end of the catheter body and close to theouter surface of the catheter body in the thickness of the wall of thecatheter body.

According to an optional aspect of the invention, a thickness of thesidewall of said tip is minimized at the distal end where the sensingelement is positioned.

This way, the accuracy of the measurement of the sensing element ismaximized and the response time of the sensing element is minimized.

According to an optional aspect of the invention, the temperature sensorlumen is separate in the catheter body from the inflow lumen andseparate from the outflow lumen.

This way, the temperature sensor and the sensing element according tothe present invention are never in direct contact with the fluid in thecatheter body. The temperature sensor and the sensing element accordingto the present invention are therefore never contaminated by directcontact with a fluid in body cavity when measuring the temperature ofthe fluid. Additionally, the temperature sensor according to the presentinvention may be removed from the catheter, and because neither thetemperature sensor nor the sensing element have ever been contaminatedby direct contact with a fluid, the temperature sensor and the sensingelement never endanger the patient's health.

According to an optional aspect of the invention, the catheter is alavage catheter.

This way, the fluid can inflow in the body cavity via the irrigationopening and the fluid after having flown in the body cavity can flow outof the body cavity via the drainage opening. This way, there is acirculation of fluid in the body cavity, which allows for thetherapeutic irrigation or lavage.

According to an optional aspect of the invention, the inflow lumen andthe outflow lumen are configured to be coupled at the proximal end ofthe catheter body to a fluid circulation system; and the distal end ofthe catheter body is configured to be inserted into the body cavity.

For example, the proximal end of the catheter body comprises one or morevalves which allow the connection of the proximal end of the catheter tofor example devices and systems. For example, the proximal end of thecatheter body comprises a valve to which a fluid circulation system isconnected. This way, fluid is delivered from the fluid circulationsystem by the inflow lumen to the body cavity via the irrigation openingand fluid is drained towards the fluid circulation system by the outflowlumen via the drainage opening, thereby creating a fluid circulation inthe body cavity. For example, the temperature sensor according to thepresent invention is introduced in the catheter body through one of thevalve and is advanced in the temperature sensor lumen along alongitudinal direction of the catheter body until the sensing element ispositioned at the tip of the distal end of the catheter body.

According to an optional aspect of the invention, the inflow lumen isfurther configured to allow a fluid of the fluid circulation system toflow from the proximal end to the body cavity through the irrigationopening; and wherein the outflow lumen is further configured to allowthe fluid to flow out from the body cavity through the drainage openingto the proximal end.

According to an optional aspect of the invention, the catheter is aurinary catheter and the distal end is configured to be inserted into abladder of a patient.

According to an optional aspect of the invention, the temperature sensorlumen extends in the catheter body from the proximal end to the distalend.

This way, the sensing element may be introduced at the proximal end ofthe catheter body and may then be advanced in the temperature sensorlumen towards the distal end of the catheter body until the sensingelement reaches the tip of the distal end and remains in this positionwhen measuring the temperature of a fluid flowing in the body cavity.Alternatively, the temperature sensor lumen extends from the distal endof the catheter body to a position along the catheter body which is notintroduced in the body cavity when the catheter is under use. This way,the temperature sensor lumen remains available from the outside world tointroduce the sensing element for measurement.

According to an optional aspect of the invention, the temperature sensorfurther comprises an electrical wire extending along the temperaturesensor lumen between the sensing element and the proximal end of thecatheter body.

This way, the data comprising information indicative for the temperaturemeasurement performed by the sensing element is communicated to a remotesystem where the data can be analyzed and the temperature of the fluidin the body cavity can be determined. Alternatively, the sensing elementtransmits the temperature measurement wirelessly to a remote dataanalyzing system.

According to an optional aspect of the invention, the inflow lumen andthe outflow lumen are not in fluid communication.

According to an optional aspect of the invention, a diameter of theoutflow lumen is larger than a diameter of the inflow lumen.

According to an optional aspect of the invention, the catheter bodyfurther comprises an inflation balloon.

This way, when the catheter is introduced in the body cavity, theinflation balloon may be inflated to hold the catheter in the bodycavity. When the inflation balloon is inflated, the diameter of theballoon is not to exceed four French sizes over the actual outerdiameter of the catheter body, except for the 16FR which shall notexceed six French sizes over the actual outer diameter of the catheterbody.

According to an optional aspect of the invention, the fluid is atherapeutic fluid.

According to a second aspect of the invention, there is provided amethod for manufacturing a catheter for measuring temperature of a fluidin a body cavity, wherein the catheter comprises a catheter bodycomprising a proximal end and an opposite distal end comprising a tip;wherein the method comprises the steps of:

-   -   providing a catheter for measuring temperature of a fluid in a        body cavity, wherein the catheter comprises a catheter body        comprising a proximal end and an opposite distal end comprising        a tip;    -   forming an irrigation opening in a sidewall of the tip;    -   providing an inflow lumen extending from the irrigation opening        to the proximal end;    -   forming a drainage opening in the sidewall of the tip;    -   providing an outflow lumen extending from the drainage opening        to the proximal end;    -   providing a temperature sensor lumen comprising a temperature        sensor, wherein the temperature sensor comprises a sensing        element;    -   arranging the temperature sensor lumen closer to the outflow        lumen than to the inflow lumen in the catheter body; and    -   positioning the sensing element in the temperature sensor lumen        at the tip of the distal end such that the sensing element        measures a temperature of a fluid in a body cavity when the        distal end of the catheter body is inserted into a body cavity.

The catheter according to the present invention is used to deliver afluid for lavage purposes and/or for therapeutic purposes and/or fordiagnosis purposes to a body cavity of a patient in the context of alocalized treatment of a specific body cavity. The catheter according tothe present invention directly delivers the fluid to the body cavity asthe catheter is introduced directly into the body cavity. The efficiencyof the fluid on the body cavity is therefore maximized: the fluid isonly delivered in the body cavity. The precision of thetreatment/diagnosis is also maximized. The impact of the treatmentand/or diagnosis on the patient is also minimized as the delivery of thefluid is local and does not spread to the whole body of the patient. Aninflow lumen is arranged in the catheter body to deliver a fluid to thebody cavity when the catheter is introduced in the body cavity. Anoutflow lumen is arranged in the catheter body to drain a fluid from thebody cavity when the catheter is introduced in the body cavity. Thecatheter according to the present invention allows an indirect andaccurate measurement of the temperature of a fluid in a body cavity whenthe catheter is introduced in the body cavity. The catheter according tothe present invention comprises an integrated temperature sensor,wherein the sensing element is positioned at the tip of the distal endof the catheter. When the distal end of the catheter according to thepresent invention is introduced into a body cavity, the sensing elementis positioned as close as possible to the fluid in the body cavity. Thesensing element is in direct contact with the tip of the catheter body.The outside surface of the tip of the catheter body is in direct contactwith the fluid in the body cavity. The sensing element measures thetemperature of the fluid through the tip of the catheter body. In otherwords, the temperature sensor according to the present inventionindirectly measures the temperature of the fluid. The sensing elementaccording to the present invention is arranged in the catheter bodycloser to the outflow lumen than to the inflow lumen. By being closer tothe outflow lumen than to the inflow lumen in the catheter body, thesensing element according to the present invention allows a moreaccurate and a more reliable measurement of the temperature of a fluidin the body cavity. The sensing element according to the presentinvention provides a user of the catheter with a more realistic feedbackon the actual temperature of the fluid in the body cavity. The sensingelement according to the present invention can for example indirectlymeasure the temperature of a fluid in a body cavity. The catheteraccording to the present invention can for example indirectly measurethe temperature of a fluid in a body cavity with an accuracy comprisedbetween +/−1° C. and +/−0.1° C., preferably with an accuracy orprecision comprised between or equal to +/−0.5° C. and +/−0.1° C.

According to the present invention, the catheter body comprises atemperature sensor lumen which is configured to host the temperaturesensor. The temperature sensor lumen is formed in the catheter body. Thetemperature sensor lumen is independent from the inflow lumen, and thetemperature sensor lumen is also independent from the outflow lumen. Inother words, the temperature sensor lumen is neither in fluidcommunication with the inflow lumen nor in fluid communication with theoutflow lumen. This way, the temperature sensor and the sensing elementaccording to the present invention are never in direct contact with thefluid in the catheter body. The temperature sensor and the sensingelement according to the present invention are therefore nevercontaminated by direct contact with a fluid in body cavity whenmeasuring the temperature of the fluid. Additionally, the temperaturesensor according to the present invention may be removed from thecatheter, and because neither the temperature sensor nor the sensingelement have ever been contaminated by direct contact with a fluid, thetemperature sensor and the sensing element never endanger the patient'shealth.

The outflow lumen and the inflow lumen according to the presentinvention are independent from each other in the catheter body. In otherwords, the outflow lumen and the inflow lumen are arranged side by sidein the catheter body of the catheter according to the present invention.In other words, the outflow lumen and the inflow lumen are arranged nextto each other in the catheter body. Alternatively, the outflow lumencomprises the inflow lumen. In other words, the outflow lumen and theinflow lumen can alternatively be in fluid communication with each otherwhen the inflow lumen is completely comprised in the outflow lumen. Thisway, the footprint of the catheter body is significantly reduced.

The distal end of the catheter body is designed to be easily introducedinto the body cavity, without injuring the patient. For example, the tipof the catheter comprises silicon, such as for example clear silicone.Alternatively, the tip of the catheter according to the presentinvention comprises blue radiopaque silicone. The tip of the distal endof the catheter for example comprises clear 60 ShA silicone such as forexample EL R402/60 and barium sulfate Blanc Fixe Grade HD 80. Accordingto the present invention, the catheter body comprises silicone, such asfor example silicone rubber. This way, the catheter body is heatresistant, low-temperature flexible and resistant to UV, ozone andradiation aging. Alternatively, the catheter body comprisespolycarbonate. This way, the catheter is hygienic, easy and cheap tofabricate in series and in large quantities, and it can easily bedisposed. Alternatively, the catheter body is made of thermoplastic.Alternatively, a catheter inflation valve comprises a polypropylenebody. All materials used in the catheter according to the presentinvention are to meet ANSI/AAMI/ISO 10993-1:2003 requirements. Thecatheter body according to the present invention is cylindrical and hasa diameter to conform to the French scale or French gauge systemcommonly used to measure the size of a catheter. The French size isthree times the diameter in millimeters. For example, the French size ofthe catheter according to the present invention is 16. Alternatively,the French size of the catheter according to the present invention is18. The French size is understood in the context of the presentinvention as a measure of the outer diameter of a catheter.

According to the present invention, the sensing element is for example athermistor. More particularly, the sensing element according to thepresent invention is for example a coated thermistor used to minimizethe risk of health hazard for the patient when the catheter isintroduced into a body cavity. For example, the sensing elementaccording to the present invention comprises a housing comprisingpolyvinyl chloride or PVC, such as for example a white medical gradePVC. The sensing element may further comprise a thermistor side portwith comprises silicone such as a silicone rubber. This way, the sensingelement is heat resistant, low-temperature flexible and resistant to UV,ozone and radiation aging. Alternatively, the temperature sensor is athermocouple, a resistance thermometer, a silicon bandgap temperaturesensor, a thermostatic switch, an infra-red temperature sensor, etc.

According to the present invention, a body cavity is for example anatural body cavity, such as for example a bladder, a stomach, anabdomen, a lung, etc. . . . Alternatively, a body cavity in the contextof the present invention is for example an artificial body cavity, suchas for example the abdomen of a patient closed by a surgeon duringsurgery, or an artefact enclosing a part or the entirety of an organ ofa patient in which the circulation of a fluid delivered by the catheterwould occur.

A fluid according to the present invention is a highly concentrated,heated fluid directly delivered to a body cavity of a patient duringlavage or therapeutic irrigation in the context of a treatment or adiagnosis. For example, a fluid according to the present invention maynot comprise chemotherapeutic agents. Alternatively, a fluid accordingto the present invention is any suitable irrigant and/or solution whichmay be delivered to a body cavity by a catheter. For example, a fluidaccording to the present invention is a normal saline solution.Alternatively, a fluid according to the present invention is a highlyconcentrated, heated therapeutic fluid directly delivered to the bladderof the patient before, immediately after of after TransurethralResection of Bladder Tumors surgery, also referred to as TURBT surgery.Alternatively, a fluid according to the present invention is a highlyconcentrated, heated therapeutic fluid directly delivered to the bladderof the patient before, immediately after of after a hyperthermicintra-vesical chemotherapy treatment, also referred to as HIVEC.Alternatively, a fluid according to the present invention is any fluidwhich is suitable and compatible with a hyperthermic treatment, or anytherapeutic fluid and/or nutritive agents and/or chemotherapeutic fluidsand/or immunotherapy fluids delivered during a treatment or a diagnosis.The fluid according to the present invention has a temperature comprisedbetween 37 and 45° C., more particularly comprised between 39.5 and40.5° C., or more particularly comprised between 41.8 and 42° C., ormore particularly comprised between 43 and 44° C. when it is in the bodycavity. Delivery of the fluid to the body cavity can for example lastseveral minutes, preferably one hour, or several hours.

According to the present invention, the inner diameter of the outflowlumen is larger than the inner diameter of the inflow lumen. Moreparticularly, a ratio of the inner diameter of the inflow lumen over theinner diameter of the outflow lumen is comprised between 0.6 and 1. Thisway, obstructions in the outflow lumen due to body tissues being drainedfrom the body cavity are prevented. Additionally, potential pressureissues in the fluid circulation system formed by the catheter areprevented thanks to a larger inner diameter of the outflow lumen thanthe inner diameter of the inflow lumen. This way, fluid that has alreadyflown in the body cavity does not flow back into the inflow lumen. Therisk of contamination of the inflow lumen by fluid that has been incontact with tissue is therefore lowered. The catheter according to thepresent invention is for example designed to meet or exceed a flow rateper A.S.T.M. F623-99 method for Foley catheters.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically illustrates an embodiment of a catheter accordingto the present invention.

FIG. 2 schematically illustrates an embodiment of a catheter accordingto the present invention when the catheter is introduced into a bodycavity of a patient.

FIG. 3 schematically illustrates an embodiment of a cross-section of thedistal end of a catheter according to the present invention.

FIG. 4 schematically illustrates an embodiment of a cross-section of thecatheter body according to the present invention.

FIG. 5 schematically illustrates an embodiment of the steps of themethod according to the present invention.

DETAILED DESCRIPTION OF EMBODIMENT(S)

According to an embodiment shown in FIG. 1, a catheter 1 for measuringtemperature of a fluid 2 in a body cavity comprises a catheter body 100.The catheter body 100 extends along a longitudinal direction 6. Thetraverse direction 5 and the direction 7 traverse to the longitudinaldirection 6 and to the traverse direction 5 are also indicated onFIG. 1. The catheter body comprises a proximal end 101 and an oppositedistal end 102. The distal end 102 comprises a tip 103. The catheterbody 100 comprises an irrigation opening 111 from which fluid 2 isallowed flowing from the catheter body 100 to the body cavity. Thecatheter body 100 also comprises a drainage opening 121 from which fluid2 is allowed flowing from the body cavity to the catheter body 100. Atemperature sensor comprises a sensing element 131 positioned at the tip103 of the distal end 102. The sensing element 131 measures atemperature of a fluid 2 in the body cavity when the distal end 102 ofthe catheter body 100 is introduced in a body cavity. Optionally, thecatheter body 100 further comprises an inflation balloon 4. The sensingelement 131 is positioned closer to the drainage opening 121 than to theirrigation opening 111 in the catheter body 100. A thickness of thesidewall of the tip 103 is minimized at the distal end 102 where thesensing element 131 is positioned. The catheter body 100 is coupled atits proximal end 101 to a fluid circulation system 3 and the distal end102 is to be inserted into a body cavity 10. For example, the catheter 1further comprises a funnel at the proximal end 101 which serves as adrain port for the outflow lumen, wherein the funnel is connected to theoutflow lumen on one end and to the fluid circulation system 3 on anopposite end. Such a funnel for example comprises clear 60 ShA silicon,such as for example Elastosil LR 3003/60 A/B LSR. For example, thecatheter body 100 of the catheter 1 comprises clear 70 ShA silicone,such as for example Silbione HCRA 4170 A/B HC. The catheter 1 forexample further comprises an irrigation funnel at the proximal end 101which serves as an irrigation port for the inflow lumen, wherein theirrigation funnel is connected to the inflow lumen on one end and to thefluid circulation system 3 on an opposite end. The catheter 1 forexample further comprises an inflation valve at the proximal end 101,wherein the inflation valve is connected to the catheter body 100 on oneend and to an inflation system for inflating the inflation balloon 4 onan opposite end. For example, the inflation valve is a Luer inflationvalve comprising for example a polypropylene body. The inflation valvefor example comprises an inflation valve collar which comprisesAcrylonitrile Butadiene Styrene or ABS, such as for example LUSTRANABS348. A pigment of a first colour can be added to the LUSTRAN ABS348for example for the 16FR catheter 1 and a pigment of second colourdifferent from the first colour can be added to the LUSTRAN ABS348 forexample for the 18FR catheter 1 such as the catheters 1 can bedistinguished from each other. The inflation balloon 4 is for example a20 mL inflation balloon.

According to an alternative embodiment, the inflation balloon may have adifferent volume suitable for the specific application.

According to an embodiment shown in FIG. 2, a catheter 1 for measuringtemperature of a fluid 2 in a body cavity 10 comprises a catheter body100. The catheter body 100 extends along a longitudinal direction 6. Thetraverse direction 5 and the direction 7 traverse to the longitudinaldirection 6 and to the traverse direction 5 are also indicated on FIG.2. Components having identical reference numbers than on FIG. 1 performthe same function. The catheter body comprises a proximal end 101 and anopposite distal end 102. The distal end 102 comprises a tip 103. Thecatheter body 100 comprises an irrigation opening 111 from which fluid 2is allowed flowing from the catheter body 100 to the body cavity 10. Thecatheter body 100 also comprises a drainage opening 121 from which fluid2 is allowed flowing from the body cavity 10 to the catheter body 100.The body cavity is represented by the dash-dotted line on FIG. 2. Thefluid 2 is allowed to flow freely in the body cavity of FIG. 2. Atemperature sensor comprises a sensing element 131 positioned at the tip103 of the distal end 102. The sensing element 131 measures atemperature of a fluid 2 in the body cavity 10 when the distal end 102of the catheter body 100 is introduced in a body cavity 10. Optionally,the catheter body 100 further comprises an inflation balloon 4 which isinflated when the distal end 102 of the catheter body 100 is introducedinto a body cavity 10. The sensing element 131 is positioned closer tothe drainage opening 121 than to the irrigation opening 111 in thecatheter body 100. A thickness of the sidewall of the tip 103 isminimized at the distal end 102 where the sensing element 131 ispositioned. The catheter body 100 is coupled at its proximal end 101 toa fluid circulation system 3 and the distal end 102 is to be insertedinto a body cavity 10.

According to an embodiment shown in FIG. 3, a cross-section of thedistal end 102 of a catheter body 100 of the catheter 1 is depicted. Thecatheter body 100 extends along a longitudinal direction 6. The traversedirection 5 and the direction 7 traverse to the longitudinal direction 6and to the traverse direction 5 are also indicated on FIG. 3. Thecross-section is defined along the longitudinal direction 6 of thecatheter body 100 and along the direction 7 traverse to the longitudinaldirection 6 and the traverse direction 5. Components having identicalreference numbers than on FIG. 1 or 2 perform the same function. Thedistal end 102 comprises a tip 103. The catheter body 100 comprises anoutflow lumen 12 and a temperature sensor lumen 13. The temperaturesensor lumen 13 is arranged closed to the outflow lumen 12 than to theinflow lumen 11 in the catheter body 100. The outflow lumen 11 comprisesa drainage opening 121 from which fluid 2 is allowed flowing from thebody cavity 10 to the catheter body 100. The temperature sensor lumen 13comprises a temperature sensor 130. The temperature sensor 130 comprisesa sensing element 131 positioned at the tip 103 of the distal end 102.The sensing element 131 measures a temperature of a fluid in the bodycavity when the distal end 102 of the catheter body 100 is introduced ina body cavity. The sensing element 131 is positioned closer to thedrainage opening 121 than to the irrigation opening in the catheter body100. A thickness of the sidewall 110 of the tip 103 along the direction7 is minimized at the distal end 102 where the sensing element 131 ispositioned. A thickness of the sidewall 271 of the tip 103 along thelongitudinal direction 6 is minimized at the distal end 102 where thesensing element 131 is positioned. The temperature sensor lumen 13 isseparate in the catheter body 100 from the outflow lumen 12 and alsofrom the inflow lumen. The temperature sensor 130 further comprises anelectrical wire 132 extending in the temperature sensor lumen 13 andalong the longitudinal direction 6 of the catheter body 100. Theelectrical wire 132 extends preferably between the sensing element 131and the proximal end of the catheter body 100.

According to an embodiment shown in FIG. 4, a cross-section of thecatheter body 100 of the catheter 1 is depicted. The catheter body 100extends along a longitudinal direction 6. The traverse direction 5 andthe direction 7 traverse to the longitudinal direction 6 and to thetraverse direction 5 are also indicated on FIG. 4. The cross-section isdefined along the direction 7 traverse to the longitudinal direction 6and to the traverse direction 5 of the catheter body 100. Componentshaving identical reference numbers than on FIG. 1 or 2 or 3 perform thesame function. The catheter body 100 comprises an inflow lumen 11, anoutflow lumen 12 and a temperature sensor lumen 13. Optionally, thecatheter body 100 further comprises an inflation balloon 4 which isinflated when the distal end of the catheter 1 is introduced in a bodycavity to keep the catheter 1 in the body cavity. The temperature sensorlumen 13 is arranged closer to the outflow lumen 12 than to the inflowlumen 11 in the catheter body 100. Preferably, the distance 141 betweenthe temperature sensor lumen 13 in which the sensing element 131 ispositioned and the outflow lumen 12 is twice the distance 142 betweenthe temperature sensor lumen 13 and the inflow lumen 11. According to analternative embodiment, the distance 141 between the temperature sensorlumen 13 in which the sensing element 131 is positioned and the outflowlumen 12 is more than twice the distance 142 between the temperaturesensor lumen 13 and the inflow lumen 11, for example three, four, five,six, etc., times the distance 142 between the temperature sensor lumen13 and the inflow lumen 11. A thickness of the sidewall 110 of the tip103 is minimized at the distal end 102 where the sensing element 131 ispositioned in the temperature sensor lumen 13. The inner diameter 143 ofthe outflow lumen 13 is larger than the inner diameter 144 of the inflowlumen 11. More particularly, a ratio of the inner diameter 144 of theinflow lumen 11 over the inner diameter 143 of the outflow lumen 13 iscomprised between 0.6 and 1. This way, obstructions in the outflow lumen13 due to body tissues being drained from the body cavity are prevented.The inner diameter 143 of the outflow lumen 13 is schematically depictedas extending along the direction 7 on FIG. 4. According to analternative embodiment, the inner diameter 143 of the outflow lumen 13could extend along any direction of the catheter body 100. The innerdiameter 144 of the inflow lumen 11 is schematically depicted asextending along the direction 7 on FIG. 4. According to an alternativeembodiment, the inner diameter 144 of the inflow lumen 11 could extendalong any direction of the catheter body 100. For example, for acircular 16 French catheter having a diameter of 0.210 inches, thedistance 141 between the temperature sensor lumen 13 and the outflowlumen 12 is for example 0.010 inches, which is the minimum internal wallthickness which can be manufactured; the distance 142 between thetemperature sensor lumen 13 and the inflow lumen 11 is for example 0.025inches; the distance 149 between the outflow lumen 12 and the inflowlumen 11 is for example 0.017 inches; the length 143 of the outflowlumen 12 along the direction 7 is for example 0.113 inches; the length145 of the outflow lumen 12 along the traverse direction 5 is forexample 0.064 inches; the length 144 of the inflow lumen 11 along thedirection 7 is for example 0.084 inches; the length 146 of the inflowlumen 11 along the traverse direction 5 is for example 0.056 inches; thelength 147 of the temperature sensor lumen 13 along the direction 7 isfor example 0.047 inches; the length 148 of the temperature sensor lumen13 along the traverse direction 5 is for example 0.070 inches; theinflation balloon 4 has for example a diameter of 0.033 inches; and thethickness of the sidewall 110 of the catheter 1 is, where the sensingelement 131 is, for example 0.012 inches. For example, for a circular 18French catheter having a diameter of 0.236 inches, the distance 141between the temperature sensor lumen 13 and the outflow lumen 12 is forexample 0.014 inches; the distance 142 between the temperature sensorlumen 13 and the inflow lumen 11 is for example 0.034 inches; thedistance 149 between the outflow lumen 12 and the inflow lumen 11 is forexample 0.018 inches; the length 143 of the outflow lumen 12 along thedirection 7 is for example 0.132 inches; the length 145 of the outflowlumen 12 along the traverse direction 5 is for example 0.083 inches; thelength 144 of the inflow lumen 11 along the direction 7 is for example0.080 inches; the length 146 of the inflow lumen 11 along the traversedirection 5 is for example 0.051 inches; the length 147 of thetemperature sensor lumen 13 along the direction 7 is for example 0.055inches; the length 148 of the temperature sensor lumen 13 along thetraverse direction 5 is for example 0.080 inches; the inflation balloon4 has for example a diameter of 0.035 inches; and the thickness of thesidewall 110 of the catheter 1, where the sensing element 131 is, is forexample 0.016 inches. According to an alternative embodiment, the inflowlumen 11 and the outflow lumen 12 have a circular cross-section along aplane comprising the longitudinal direction 6 and to the traversedirection 5 of the catheter body 100 and the diameter of the outflowlumen 12 defined along this cross-section is preferably larger than thediameter of the inflow lumen 11 defined along this cross-section. Forexample, the diameter of the outflow lumen 12 is 1.1 times larger thanthe diameter of the inflow lumen 11. According to alternativeembodiments, the diameter of the outflow lumen 12 is for example 1.2times larger than the diameter of the inflow lumen 11, or 1.3 times, or1.4 times, or 1.5 times, or 1.6 times, etc.

The steps of a method according to the present invention formanufacturing a catheter 1 for measuring a temperature of a fluid 2 in abody cavity 10 are depicted on FIG. 5. In step 501, the method comprisesproviding a catheter body 10 comprising a proximal end 101 and anopposite distal end 102 comprising a tip 103. In step 502, an irrigationopening 111 is then formed in the sidewall 110 of the tip 103. In step503, an inflow lumen 11 is formed and is extended from the irrigationopening 111 to the proximal end 102. In step 504, a drainage opening 121is then formed in the sidewall 110 of the tip 103. In step 505, anoutflow lumen 12 is formed and is extending from the drainage opening121 to the proximal end 102. In step 506, a temperature sensor lumen 13is formed. The temperature sensor lumen 13 is provided with atemperature sensor 130, wherein the temperature sensor 130 comprises asensing element 131. In step 507, the temperature sensor lumen 13 isarranged closer to the outflow lumen 12 than to the inflow lumen 11 inthe catheter body 100. Finally, in step 508, the sensing element 131 ispositioned in the temperature sensor lumen 13 at the tip 103 of thedistal end 102 such that the sensing element 131 measures a temperatureof a fluid 2 inside a body cavity 10 when the distal end 102 of thecatheter body 100 is inserted into a body cavity 10.

Although the present invention has been illustrated by reference tospecific embodiments, it will be apparent to those skilled in the artthat the invention is not limited to the details of the foregoingillustrative embodiments, and that the present invention may be embodiedwith various changes and modifications without departing from the scopethereof. The present embodiments are therefore to be considered in allrespects as illustrative and not restrictive, the scope of the inventionbeing indicated by the appended claims rather than by the foregoingdescription, and all changes which come within the meaning and range ofequivalency of the claims are therefore intended to be embraced therein.In other words, it is contemplated to cover any and all modifications,variations or equivalents that fall within the scope of the basicunderlying principles and whose essential attributes are claimed in thispatent application. It will furthermore be understood by the reader ofthis patent application that the words “comprising” or “comprise” do notexclude other elements or steps, that the words “a” or “an” do notexclude a plurality, and that a single element, such as a computersystem, a processor, or another integrated unit may fulfil the functionsof several means recited in the claims. Any reference signs in theclaims shall not be construed as limiting the respective claimsconcerned. The terms “first”, “second”, third”, “a”, “b”, “c”, and thelike, when used in the description or in the claims are introduced todistinguish between similar elements or steps and are not necessarilydescribing a sequential or chronological order. Similarly, the terms“top”, “bottom”, “over”, “under”, and the like are introduced fordescriptive purposes and not necessarily to denote relative positions.It is to be understood that the terms so used are interchangeable underappropriate circumstances and embodiments of the invention are capableof operating according to the present invention in other sequences, orin orientations different from the one(s) described or illustratedabove.

1-15. (canceled)
 16. A catheter for measuring temperature of a fluid ina body cavity, wherein said catheter comprises a catheter bodycomprising a proximal end and an opposite distal end comprising a tip;and wherein said catheter body further comprises: an inflow lumenextending from an irrigation opening in a sidewall of said tip to saidproximal end; an outflow lumen extending from a drainage opening in saidsidewall of said tip to said proximal end; and a temperature sensorlumen comprising a temperature sensor; wherein said temperature sensorlumen is arranged closer to said outflow lumen than to said inflow lumenin said catheter body; and wherein said temperature sensor comprises asensing element positioned in said temperature sensor lumen at said tipof said distal end; and wherein said sensing element is configured tomeasure a temperature of a fluid in a body cavity when said distal endof said catheter body is inserted into a body cavity.
 17. The catheteraccording to claim 16, wherein said sensing element is positioned closerto said drainage opening than to said irrigation opening in saidcatheter body.
 18. The catheter according to claim 16, wherein saidtemperature sensor lumen is arranged in said catheter body at the outerperiphery of said catheter body.
 19. The catheter according to claim 16,wherein a thickness of said sidewall of said tip is minimized at saiddistal end where said sensing element is positioned.
 20. The catheteraccording to claim 16, wherein said temperature sensor lumen is separatein said catheter body from said inflow lumen and separate from saidoutflow lumen.
 21. The catheter according to claim 16, wherein saidcatheter is a lavage catheter.
 22. The catheter according to claim 16,wherein said inflow lumen and said outflow lumen are configured to becoupled at said proximal end of said catheter body to a fluidcirculation system; and wherein said distal end of said catheter body isconfigured to be inserted into said body cavity.
 23. The catheteraccording to claim 22, wherein said inflow lumen is further configuredto allow a fluid of said fluid circulation system to flow from saidproximal end to said body cavity through said irrigation opening; andwherein said outflow lumen is further configured to allow said fluid toflow out from said body cavity through said drainage opening to saidproximal end.
 24. The catheter according to claim 16, wherein saidcatheter is a urinary catheter and wherein said distal end is configuredto be inserted into a bladder of a patient.
 25. The catheter accordingto claim 16, wherein said temperature sensor lumen extends in saidcatheter body from said proximal end to said distal end.
 26. Thecatheter according to claim 10, wherein said temperature sensor furthercomprises an electrical wire extending along said temperature sensorlumen between said sensing element and said proximal end of saidcatheter body.
 27. The catheter according to claim 16, wherein saidinflow lumen and said outflow lumen are not in fluid communication. 28.The catheter according to claim 16, wherein a diameter of said outflowlumen is larger than a diameter of said inflow lumen.
 29. The catheteraccording to claim 16, wherein said catheter body further comprises aninflation balloon.
 30. A method for manufacturing a catheter formeasuring temperature of a fluid in a body cavity, wherein said cathetercomprises a catheter body comprising a proximal end and an oppositedistal end comprising a tip; wherein said method comprises the steps of:providing a catheter body comprising a proximal end and an oppositedistal end comprising a tip; forming an irrigation opening in a sidewallof said tip; providing an inflow lumen extending from said irrigationopening to said proximal end; forming a drainage opening in saidsidewall of said tip; providing an outflow lumen extending from saiddrainage opening to said proximal end; providing a temperature sensorlumen comprising a temperature sensor, wherein said temperature sensorcomprises a sensing element; arranging said temperature sensor lumencloser to said outflow lumen than to said inflow lumen in said catheterbody; and positioning said sensing element in said temperature sensorlumen at said tip of said distal end such that said sensing elementmeasures a temperature of a fluid in a body cavity when said distal endof said catheter body is inserted into a body cavity.